CAN CSA-C22 2 NO 60601-2-30-2002 Medical Electrical Equipment – Part 2-30 Particular Requirements for the Safety Including Essential Performance of Automatic Cycling Non-Invasive B.pdf

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1、Medical electrical equipment Part 2-30:Particular requirements for the safety,including essential performance,of automatic cycling non-invasiveblood pressure monitoring equipmentAppareils lectromdicaux Partie 2-30:Rgles particulires de scurit et performancesessentielles des appareils de surveillance

2、de la pression sanguine prleve indirectement,automatiquement et priodiquementReference numberIEC 60601-2-30:1999(E)National Standard of CanadaCAN/CSA-C22.2 No. 60601-2-30:02(IEC 60601-2-30:1999)International Standard IEC 60601-2-30:1999 (second edition, 1999-12) has been adopted without modification

3、(IDT) as CSA Standard CAN/CSA-C22.2 No. 60601-2-30:02, which has been approved as a National Standard ofCanada by the Standards Council of Canada.ISBN 1-55324-634-9 June 2002NumberingAs from 1 January 1997 all IEC publications are issued with a designation in the60000 series.Consolidated publication

4、sConsolidated versions of some IEC publications including amendments areavailable. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to thebase publication, the base publication incorporating amendment 1 and the basepublication incorporating amendments 1 and 2.Validity of this publi

5、cationThe technical content of IEC publications is kept under constant review by the IEC,thus ensuring that the content reflects current technology.Information relating to the date of the reconfirmation of the publication is availablein the IEC catalogue.Information on the subjects under considerati

6、on and work in progress undertakenby the technical committee which has prepared this publication, as well as the listof publications issued, is to be found at the following IEC sources: IEC web site* Catalogue of IEC publicationsPublished yearly with regular updates(On-line catalogue)* IEC BulletinA

7、vailable both at the IEC web site* and as a printed periodicalTerminology, graphical and letter symbolsFor general terminology, readers are referred to IEC 60050: InternationalElectrotechnical Vocabulary (IEV). For graphical symbols, and letter symbols and signs approved by the IEC forgeneral use, r

8、eaders are referred to publications IEC 60027: Letter symbols to beused in electrical technology, IEC 60417: Graphical symbols for use on equipment.Index, survey and compilation of the single sheets and IEC 60617: Graphical symbolsfor diagrams.* See web site address on title page.The Canadian Standa

9、rds Association (CSA), The Standards Council of Canada is theunder whose auspices this National Standard has been coordinating body of the National Standards system, produced, was chartered in 1919 and accredited by a federation of independent, autonomousthe Standards Council of Canada to the Nation

10、al organizations working towards the furtherStandards system in 1973. It is a not-for-profit, development and improvement of voluntarynonstatutory, voluntary membership association standardization in the national interest.engaged in standards development and certification The principal objects of th

11、e Council are to foster activities. and promote voluntary standardization as a means CSA standards reflect a national consensus of of advancing the national economy, benefiting theproducers and users including manufacturers, health, safety, and welfare of the public, assisting consumers, retailers,

12、unions and professional and protecting the consumer, facilitating domestic organizations, and governmental agencies. The and international trade, and furthering internationalstandards are used widely by industry and commerce cooperation in the field of standards.and often adopted by municipal, provi

13、ncial, and A National Standard of Canada is a standard whichfederal governments in their regulations, particularly in has been approved by the Standards Council ofthe fields of health, safety, building and construction, Canada and one which reflects a reasonableand the environment. agreement among t

14、he views of a number of capableIndividuals, companies, and associations across individuals whose collective interests provide to theCanada indicate their support for CSAs standards greatest practicable extent a balance ofdevelopment by volunteering their time and skills to representation of producer

15、s, users, consumers, andCSA Committee work and supporting the Associations others with relevant interests, as may be appropriateobjectives through sustaining memberships. The more to the subject in hand. It normally is a standardthan 7000 committee volunteers and the 2000 which is capable of making

16、a significant and timelysustaining memberships together form CSAs total contribution to the national interest.membership from which its Directors are chosen. Approval of a standard as a National Standard ofSustaining memberships represent a major source of Canada indicates that a standard conforms t

17、o theincome for CSAs standards development activities. criteria and procedures established by the StandardsThe Association offers certification and testing Council of Canada. Approval does not refer to theservices in support of and as an extension to its technical content of the standard; this remai

18、ns thestandards development activities. To ensure the continuing responsibility of the accreditedintegrity of its certification process, the Association standards-development organization.regularly and continually audits and inspects products Those who have a need to apply standards arethat bear the

19、 CSA Mark. encouraged to use National Standards of CanadaIn addition to its head office and laboratory complex whenever practicable. These standards are subject in Toronto, CSA has regional branch offices in major to periodic review; therefore, users are cautioned centres across Canada and inspectio

20、n and testing to obtain the latest edition from the organizationagencies in eight countries. Since 1919, the preparing the standard.Association has developed the necessary expertise to The responsibility for approving National Standards meet its corporate mission: CSA is an independent of Canada res

21、ts with theservice organization whose mission is to provide an Standards Council of Canadaopen and effective forum for activities facilitating the 270 Albert Street, Suite 200exchange of goods and services through the use of Ottawa, Ontario, K1P 6N7standards, certification and related services to me

22、et Canadanational and international needs.For further information on CSA services, write toCanadian Standards Association178 Rexdale BoulevardToronto, Ontario, M9W 1R3CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the r

23、esponsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationMedical electrical equipment Part 2-30: Particular requirements forthe safety, including essential performance, of automatic cyclingCAN/CSA-C22.2 No. 60601-2-30:02

24、non-invasive blood pressure monitoring equipmentCSA/2 Canadian Standards Association June 2002CAN/CSA-C22.2 No. 60601-2-30:02Medical electrical equipment Part 2-30: Particular requirementsfor the safety, including essentialperformance, of automatic cyclingnon-invasive blood pressuremonitoring equipm

25、entCSA PrefaceThis is the second edition of CSA Standard CAN/CSA-C22.2 No. 60601-2-30, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cyclingnon-invasive blood pressure monitoring equipment, which is an adoption without m

26、odification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-30 (second edition, 1999-12),currently available from IEC in English only. It supersedes the previous edition published in 2001 under thetitle Medical electrical equipment Part 2: Particular requir

27、ements for the safety of automatic cycling indirectblood pressure monitoring equipment (adopted CEI/IEC 601-2-30:1995). It is one in a series of Standardsissued by CSA under Part II of the Canadian Electrical Code.This Standard is intended to be used in conjunction with CSA Standard CAN/CSA-C22.2 No

28、. 601.1-M90,Medical Electrical Equipment Part 1: General Requirements for Safety (adopted CEI/IEC Standard 601-1:1988, with Canadian deviations), CSA Supplement C22.2 No. 601.1S1-94 (adopted CEI/IECAmendment 1:1991), and Amendment 2:1998 (adopted CEI/IEC Amendment 2:1995).This Standard was reviewed

29、for Canadian adoption by the CSA Technical Committee on Consumer andCommercial Products, under the jurisdiction of the Strategic Resource Group, and has been formallyapproved by the Technical Committee. Due to the medical content of this Standard, it was alsoapproved by the Technical Committee on Ap

30、plications of Electricity in Health Care under the jurisdictionof the Strategic Steering Committee on Health Care Technology. Lists of the members of theseTechnical Committees are available upon request. This Standard has been approved as a NationalStandard of Canada by the Standards Council of Cana

31、da.Interpretations: The Strategic Resource Group has provided the following direction for the interpretations ofstandards under its jurisdiction: “The literal text shall be used in judging compliance of products with thesafety requirements of this Standard. When the literal text cannot be applied to

32、 the product, such as for newmaterials or construction, and when a relevant committee interpretation has not already been published,CSAs procedures for Interpretation shall be followed to determine the intended safety principle.”June 2002 Canadian Standards Association 2002All rights reserved. No pa

33、rt of this publication may be reproduced in any form whatsoever without the prior permissionof the publisher. IEC material is reprinted with permission. Where the words “this International Standard” appear in thetext, they should be interpreted as “this National Standard of Canada”. Inquiries regard

34、ing this National Standard of Canada should be addressed to Canadian Standards Association 178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1R31-800-463-6727 416-747-4044www.csa.caMedical electrical equipment Part 2-30: Particular requirements forthe safety, including essential performance, of au

35、tomatic cyclingCAN/CSA-C22.2 No. 60601-2-30:02 non-invasive blood pressure monitoring equipmentJune 2002 Canadian Standards Association CSA/3CSA ForewordThe Canadian Standards Association (CSA) develops standards under the name Canadian StandardsAssociation, and provides certification and testing un

36、der the name CSA International. CSA Internationalprovides certification services for manufacturers who, under license from CSA, wish to use theappropriate registered CSA Marks on certain products of their manufacture to indicate conformity withCSA Standards.CSA Certification for a number of products

37、 is provided in the interest of maintaining agreed-uponstandards of quality, performance, interchangeability and/or safety, as appropriate. Where applicable,certification may form the basis for acceptance by inspection authorities responsible for enforcement ofregulations. Where feasible, programs w

38、ill be developed for additional products for which certification isdesired by producers, consumers, or other interests. In performing its functions in accordance with itsobjectives, CSA does not assume or undertake to discharge any responsibility of the manufacturer or anyother party. The opinions a

39、nd findings of the Association represent its professional judgement givenwith due consideration to the necessary limitations of practical operation and state of the art at the timethe Standard is processed.Products in substantial accord with this Standard but which exhibit a minor difference or a ne

40、w featuremay be deemed to meet the Standard providing the feature or difference is found acceptable utilizingappropriate CSA International Operating Procedures. Products that comply with this Standard shall notbe certified if they are found to have additional features which are inconsistent with the

41、 intent of thisStandard. Products shall not be certifiable if they are discovered to contravene applicable laws orregulations.Testing techniques, test procedures, and instrumentation frequently must be prescribed byCSA International in addition to the technical requirements contained in Standards of

42、 CSA. In additionto markings specified in the Standard, CSA International may require special cautions, markings, andinstructions that are not specified by the Standard.Some tests required by CSA Standards may be inherently hazardous. The Association neither assumesnor accepts any responsibility for

43、 any injury or damage that may occur during or as the result of tests,wherever performed, whether performed in whole or in part by the manufacturer or the Association,and whether or not any equipment, facility, or personnel for or in connection with the test is furnishedby the manufacturer or the As

44、sociation.Manufacturers should note that, in the event of the failure of CSA International to resolve an issuearising from the interpretation of requirements, there is an appeal procedure: the complainant shouldsubmit the matter, in writing, to the Secretary of the Canadian Standards Association.If

45、this Standard is to be used in obtaining CSA Certification please remember, when making applicationfor certification, to request all current Amendments, Bulletins, Notices, and Technical Information Lettersthat may be applicable and for which there may be a nominal charge. For such information or fo

46、rfurther information concerning CSA Certification, please address your inquiry to Applications andCustomer Service, CSA International, 178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1R3.INTERNATIONALSTANDARDIEC60601-2-30Second edition1999-12Medical electrical equipment Part 2-30:Particular requ

47、irements for the safety,including essential performance,of automatic cycling non-invasiveblood pressure monitoring equipmentAppareils lectromdicaux Partie 2-30:Rgles particulires de scurit et performancesessentielles des appareils de surveillancede la pression sanguine prleve indirectement,automatiq

48、uement et priodiquementPRICE CODE IEC 1999 Copyright - all rights reservedNo part of this publication may be reproduced or utilized in any form or by any means, electronic ormechanical, including photocopying and microfilm, without permission in writing from the publisher.International Electrotechni

49、cal Commission 3, rue de Varemb Geneva, SwitzerlandTelefax: +41 22 919 0300 e-mail: inmailiec.ch IEC web site http:/www.iec.chSFor price, see current catalogueCommission Electrotechnique InternationaleInternational Electrotechnical Commission 2 60601-2-30 IEC:1999(E)CONTENTSPageFOREWORD . 4INTRODUCTION 6ClauseSECTION ONE GENERAL1 Scope and object. 72 Terminology and definitions . 83 General requirements 94 General requirements for tests 105 Classification. 106 Identification, marking and documents . 10SECTION TWO ENVIRONMENT